- CTP-656: Phase 2 Initiation Expected in 2016. Concert expects to report topline data from the Phase 1 multiple ascending dose trial evaluating three doses of CTP-656 in healthy volunteers in the second quarter 2016. Based on the results of this trial, the Company expects to advance CTP-656 into a Phase 2 clinical trial in cystic fibrosis patients with gating mutations in the second half of 2016.
- CTP- 656 Solid Dose Phase 1 Results Confirmed Superior PK Profile to Kalydeco®. The Phase 1 multiple ascending dose trial included a 150 mg single dose tablet-to-tablet comparison of CTP-656 compared to the current standard-of-care, Kalydeco (ivacaftor), both administered following a high fat meal. The results from this trial were consistent with those previously announced from Concert's single ascending dose trial, which demonstrated the superior pharmacokinetic properties of an aqueous suspension of CTP-656 compared to Kalydeco. In the current trial, the tablet formulation of CTP-656 demonstrated a longer half-life, reduced rate of clearance, substantially increased exposure and greater plasma levels at 24 hours. Also, CTP-656 provided greater plasma exposure to the parent drug relative to the less active metabolite. Overall, these results support Concert's goal of providing superior benefits to patients including a more convenient, once-daily medicine that also has the potential for improved efficacy and reduced drug-drug interactions.
- CTP-656: Food Effect Trial Initiated. In February 2016, Concert initiated a Phase 1 trial to evaluate the bioavailability and pharmacokinetics of CTP-656 under fed and fasted conditions in healthy volunteers. The trial is expected to be completed in the second quarter of 2016.
- AVP-786: Multiple Efficacy Studies Underway. Concert's collaborator, Avanir, is conducting a number of Phase 3 and Phase 2 clinical trials to evaluate the efficacy and safety of AVP-786 for neurologic and psychiatric indications.
- Two Phase 3 trials for Alzheimer's agitation were initiated in November 2015;
- A Phase 2 trial for adjunctive treatment of major depressive disorder is expected to complete in the second quarter of 2016; and
- A Phase 2 trial for residual schizophrenia was initiated in September 2015.
- CTP-730 and JZP-386: Phase 1 testing complete. In 2015, Concert completed the necessary Phase 1 clinical trials with CTP-730 and JZP-386. Celgene and Jazz Pharmaceuticals now have responsibility for further development of CTP-730 and JZP-386, respectively. Jazz Pharmaceuticals is exploring formulation options designed to leverage the positive effects observed in the Phase 1 trials. Celgene is currently assessing the data from the Phase 1 program.
- Cash and Investments. Cash, cash equivalents and investments as of December 31, 2015, totaled $142.2 million as compared to $79.2 million as of December 31, 2014. During the fourth quarter of 2015, Concert received $10.0 million in milestones including $8.0 million from Celgene and $2.0 million from Avanir. Concert expects its cash, cash equivalents and investments as of December 31, 2015 to be sufficient to fund the Company into 2018.
- Revenues. Revenue was $66.7 million for the year ended December 31, 2015, compared to $8.6 million for the year ended December 31, 2014. The increase in revenue was primarily attributable to the $50.2 million change in control payment received from Auspex Pharmaceuticals in June 2015 as a result of their acquisition by Teva Pharmaceutical Ltd.
- R&D Expenses . Research and development expenses were $28.9 million for the year ended December 31, 2015, compared to $27.5 million for the year ended December 31, 2014, an increase of $1.4 million. The increase in research and development expenses was due to higher headcount and increased expenses associated with the development of CTP-656, which were partially offset by reduced expenses associated with other programs.
- G&A Expenses. General and administrative expenses were $13.1 million for the year ended December 31, 2015, compared to $11.7 million for the year ended December 31, 2014, an increase of $1.4 million. The increase in general and administrative expenses was primarily related to compensation expenses, predominately non-cash stock-based compensation.
- Net Income (Loss). For the year ended December 31, 2015, net income attributable to common stockholders was $24.2 million, or $1.14 per share, as compared to a net loss attributable to common stockholders of $31.8 million, or $2.00 per share, for the year ended December 31, 2014. During the year ended December 31, 2015, Concert recorded a tax provision of $0.4 million related to an alternative minimum tax obligation for 2015.
|Concert Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
|Three Months Ended December 31,||Twelve Months Ended December 31,|
|License and research and development revenue||$||305||$||1,310||$||6,574||$||6,576|
|Research and development||6,386||7,068||28,885||27,474|
|General and administrative||3,256||2,987||13,056||11,700|
|Total operating expenses||9,642||10,055||41,941||39,174|
|Income (Loss) from operations||663||(8,745||)||24,788||(30,598||)|
|Interest and other income (expense), net||44||(182||)||(185||)||(1,101||)|
|Income (Loss) before income taxes||707||(8,927||)||24,603||(31,699||)|
|Provision for income taxes||23||—||429||—|
|Net income (loss)||$||684||$||(8,927||)||$||24,174||$||(31,699||)|
|Accretion on redeemable convertible preferred stock||—||—||—||(55||)|
|Net income (loss) applicable to common stockholders||$||684||$||(8,927||)||$||24,174||$||(31,754||)|
|Net income (loss) per share applicable to common stockholders—basic||$||0.03||$||(0.49||)||$||1.14||$||(2.00||)|
|Net income (loss) per share applicable to common stockholders—diluted||$||0.03||$||(0.49||)||$||1.09||$||(2.00||)|
|Weighted-average number of common shares used in net income (loss) per share applicable to common stockholders—basic||22,123||18,202||21,152||15,842|
|Weighted-average number of common shares used in net income (loss) per share applicable to common stockholders— diluted||23,302||18,202||22,267||15,842|
|Concert Pharmaceuticals, Inc.|
|Summary Balance Sheet Data|
|December 31, 2015||December 31, 2014|
|Cash and cash equivalents||$||92,510||$||13,396|
|Investments, available for sale||49,680||65,836|
|Loan payable, net of discount||—||7,101|
|Total stockholders' equity||$||130,635||$||54,825|
Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE Platform are registered trademarks of Concert Pharmaceuticals, Inc.Kalydeco is a registered trademark of Vertex Pharmaceuticals, Inc.